Evaluation of VSS Antibiotic Prophylaxis in Prosthetic Surgery (MRSA)

Recruiting

• Conditions: Infection in Bone

• Registration Number: NCT06403254
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

based on international guide lines, antibiotic prophylaxis in Orthoaedic major surgery has to be done with a Cephalosporin 1st generation (e.g. Cefazolin 1 g 30' before surgery).

Since more than 10 years ago the investigators started evaluatinf infections in such a surgery, well demosntrating a level below 1% and, more important, a responsability of MRSA. considering Cephalosporin 1st generation useful but not determinat in such a surgery, investigators consider the use of a Glycopepide (Vancocyn 1 g in Very short. The primary outcome is to evaluate the validity of such proposal, performing a study of prevalence.

Detailed Description

Patients enrolled in the study have to follow rhese steps:

T0: Clinical evaluation and Cephalosporin VSS prophylaxis, as usual T1: Surgery for TKA or THA T2: Post-operative --\> control and, if an infextion is supposed, Coltural examination and ABG T3: Post-op orthopedic control at 6 months, to evaluate any possible infection T4: Post-op clinical valuation at 12 months, with the same goal

Study Timeline

• Study Start: 2022-09-20
• Study First Submitted: 2024-01-26
• Status Verified: 2024-02
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-07
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-09
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Patiens male and female, old more than 40 years TKA or THA Surgeryntervento di chirurgia protesica ASAC II or even III, without any acute coexisting disease Informed consent -

Exclusion Criteria

Patients with infection before surgery Immunocompromise patient (e.g. Diabeties with glicate HB indicating a metabolic bad compensation) Patient with coagulation disorders Pregnancy Informed consent denied

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infections	1 year after the surgery	Orthopedic clinical control , with or without exams

Trial Locations

Locations (1)

Istitutio Ortopedico Galeazzi Sede San Siro; 🇮🇹 Milan, Lumbardy, Italy